CARBON DIOXIDE-SL ASSAY, CAT # 253-01— 510(k) K983019

Name: FDA 510(k) clearance K983019
Creator: U.S. Food and Drug Administration
Published: 1998-09-14

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K983019 for CARBON DIOXIDE-SL ASSAY, CAT # 253-01, Substantially Equivalent on 1998-09-14. Applicant: Diagnostic Chemicals , Ltd.. Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: Code KHS
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 1998-08-31
Decision date: 1998-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E.I., CA

Download summary PDF View on FDA.gov ↗

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